FDA Issues Long-Awaited 3D Printing Guidance for Medical Devices

For medical devices, 3D printing technology is much farther along.

The US Food and Drug Administration (FDA) has released a new draft guidance for medical device manufacturers working with additive manufacturing (AM), which is more commonly known as 3D printing.

In March, FDA approved the first-ever 3D printed drug, Aprecia’s epilepsy drug SPRITAM, which relies on 3D printing technology to rapidly disintegrate in a patient’s mouth, making it easier to swallow. For biologics, researchers are looking into 3D printing as a means of manufacturing cell and tissue products.